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In the United States, a boxed warning (sometimes "black box warning", colloquially) is a type of warning that appears near the beginning of the package insert for certain prescription drugs, so called because the U.S. Food and Drug Administration specifies that it is formatted with a 'box' or border around the text [1] to emphasize it is of ...
The US Food and Drug Administration has warned that antidepressants may be linked with suicidal thoughts and behaviors among youth since 2003, leading to a black box warning for minors in 2005 and ...
Methadone has the following U.S. FDA black box warning: [43] Risk of addiction and abuse; Potentially fatal respiratory depression; Lethal overdose in accidental ingestion; QT prolongation [44] Neonatal opioid withdrawal syndrome in children of pregnant women; CYP450 drug interactions; Risks when used with alcohol, benzodiazepines, and other ...
[4] [3] It has a black box warning about the risk of serious dehydration in children in the US; the most common adverse effects in others include diarrhea. [4] It is an oligopeptide agonist of guanylate cyclase 2C and remains in the GI tract after it is taken by mouth. It was approved in the US and the European Union in 2012. [7]
The recall covers over 112,000 bottles distributed nationwide.
Clozapine carries a black box warning for drug-induced agranulocytosis, although meta-analysis of controlled studies comparing the association between clozapine and other antipsychotic medications and the development of neutropenia fails to show a specific clozapine related risk, which is contrary to the previously accepted beliefs. [151]
Tramadol/paracetamol, also known as tramadol/acetaminophen and sold under the brand name Ultracet among others, is a fixed-dose combination medication used for the treatment of moderate to severe pain.
Tisotumab vedotin, sold under the brand name Tivdak, is an antibody-drug conjugate used to treat cervical cancer. [1] It is a combination of tisotumab, a monoclonal antibody against tissue factor, and monomethyl auristatin E (MMAE), a potent inhibitor of cell division. It is administered by infusion into a vein. [1]